Protalix BioTherapeutics, Inc. (PLX) 2025 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Protalix Biotherapeutics Full Year 2025 financial results and business update conference call. As a reminder, this call is being recorded. I will now turn the conference over to Mike Moyer, managing director of Life Site Advisors and investor relations representative for Protalix.

Thank you. You may begin.

Thank you, operator, and welcome to the Protalix Biotherapeutics full year 2025 financial results and business update conference call. With me today are Dror Bachan, President and Chief Executive Officer. And Protalix and also with Protalix, Gilad Mamlock, Senior Vice President and Chief Financial Officer.

A press release announcing the financial results and business updates were issued this morning and are available now on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and the teleconference include forward-looking statements.

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause the actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Pertalix's filings with the Securities and Exchange Commission. I will now turn the call over to Mr. Bachon.

Thank you Thank you everyone for joining this call. Today's discussion will include our forward-looking financial outlook which emphasizes the strength and durability of our business as we enter 2026. However, I want to first discuss our important recent news. As previously announced, the European Commission has approved a 2 mg per kg every 4 weeks dosing regimen for EFrio for adults living withebri disease who are stable with an enzyme replacement therapy.

This approval strengthens the treatment landscape for adult patients with Faris disease across the European Union by introducing an additional dosing regimen that has the potential to enhance long-term management and represent a meaningful advancement, not only for adults with living Fari's disease, but also for their families.

The FDA approved dosing regimen in the US remains 1 mg per kg every 2 weeks. Protalix is proud of this achievement. We also want to thank our partner ChiEI. This achievement is a testament to Chiei's dedicated efforts and professional execution, for which we are most appreciative.

Every 4 weeks' approval in the EU entitles us to $25 million regulatory milestone payment from TI. Having earned this milestone, we project a cash balance of approximately $50 million by early April 2026. This enables us to execute comfortably our strategy, including our clinical trials.

For 2026, we expect total revenues to range from approximately $78 million to $83 million including the $25 million milestone payment. This projection includes expected total revenues of approximately $33 million to $35 million from KI, excluding milestones and approximately 20 to $23 million from LEISO.

Gillard will walk through the full financial details later in this.

Operationally, 2025 was a year of consistent execution with our partners. KEI continued to perform well across the United States and key ex-US markets, with consistent increasing patient numbers in all markets. The recent approval of the every 4 weeks regimen in Europe significantly enhances El Fabro's competitive positioning. We remain encouraged by the long-term trajectory of the Fabri market, which is projected to reach approximately $3.4 billion by 2030. Elrio's differentiated profile and strong commercial execution strengthened its position in the market.

Turning to our pipeline, we continue to advance PRX 115 with strong momentum. Our phase 2 trial, our release study, is now enrolling, and the first patients have been randomized. We anticipate top-line results in the second half of 2027. Uncontrolled gout remains a high need indication.

We believe that PRX 115 has the potential to become a best in class therapy and ultimately our third commercial product. We are also expanding our renal pipeline with PRS 119, our long acting DNR candidate, and through our RNA based collaboration with Skarma, as well as other programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook.

Thank you.

Thank you to all. For the full year 2025, revenues from selling goods totaled $51.8 million, a moderate increase compared to 2024. This was driven by change of quantities we sold to the inventory, as well as the change in the average net selling price of the drug product due to increased commercial patients in Europe.

The increasing revenues recorded from sales to Pfizer resulted mainly from increased purchases of Relizer by Pfizer to address unexpected manufacturing issues on their end. KSI increasingly represents the majority of our long-term revenue opportunity, and revenues from KI remain at a high margin. We expect the revenue mix to shift towards KI over time, further solidifying our margin profile.

Revenues from licensed and R&D services increased to $0.9 million, mainly related to our agreements with PI. Apart from potential regulatory milestones, we continue to expect this category to remain minimal. Cost of goods sold increased to $27 million reflecting higher sales volume to Pfizer and fewer cruises, partially offset by lower sales to. R&D expenses increased to $19.6 million, rising 51% year over year. This increase was driven mainly by spending on our PRX 115 for LE study, and we expect R&D investment to continue increasing as PRX 105 and our RN programs advance.

SG&A expenses declined slightly to $11.7 million, mainly due to the lower share-based compensation expenses. Financial expenses resulted in a net expansion of 0.1 million due largely to foreign exchange effects partially offset by lower interest expenses following the full repayment of our secured convertible notes in 2024.

Income tax expense was $1 million, mainly related to US tax regulations governing global intangible lower tax income equity.

For 2025 we recorded a net loss of $6.6 million compared to a net income of $2.9 million in 2024. The loss reflects increased investment in our clinical pipeline. As of December 31-2025 we held $30.3 million in cash equivalent and short-term bank deposits. Importantly, the $25 million milestone payment triggered by the European Commission approval of the every four weeks regimen supports a projected cash balance of approximately $50 million by early April 2026, significantly strengthening our financial flexibility.

Now turning to forward-looking guidance for full year 2026, total revenue is expected to range from approximately $78 million to $83 million including the anticipated $25 million milestone from KSI.

Within that, total revenues from KSI are projected to be approximately $33 million to $35 million representing growth of more than 50%. Revenues from lizo are expected to be approximately $20 million to 23 million. We believe that our expected 2026 revenue mix driven predominantly by Ky high margin contributions, positions us well for further growth and improved profitability over time.

As always, revenues from all partners may fluctuate quarter by quarter based on their inventory management and purchasing patterns, and we encourage investors to focus on annual trends rather than quarterly viability.

In summary, we remain in a strong financial position and well capitalized to advance our key programs to the next set of clinical and commercial milestones. With that, I will turn the call back over to.

In summary, we enter 2026 with strong business flexibility driven by a projected $50 million cash position by early April, a growing commercial foundation for our partners, and a pipeline advancing towards significant clinical and commercial milestones.

Furthermore, our projected revenues growth in 2026 of greater than 50% is a testament to the growing number of patients on Efao. As we look ahead we do so from a position of strength, and we are looking forward to a productive 2026. Now I will turn to the operator and open the call for questions.

Thank you. (Operator Instructions) Ram Selvaraju, HC Wainwright. Please proceed.

Thanks so much for hearing my questions and congratulations on all the recent progress. Firstly, with respect to El Fario, can you maybe give us some insight into additional, marketing and promotional initiatives that Kyei has planned to accelerate the market uptake of this product, specifically in the United States over the course of the remainder of 2026.

And also, if you can comment on how you expect the recent approval of the less frequent dosing regimen in Europe to potentially affect the sales trajectory there, and if you can offer us any additional perspectives on how you see the timing for potential approval of this dosing regimen in the United States, that would be very helpful.

Gilard would like to take it?

Yes, so in, I think in terms of, first, thank you. In terms of marketing and promotion activities, I mean the alternative more symposium, and I think most of, the focus was on Elfario. There are many promotions they're doing. I know, we know from them that they managed to increase very nicely the naive patients and also the switch patients by, doing promotions with, patients that serve as as adults in the US, which you cannot do in the, in Europe.

In terms of the 1 to 4, effect, that is, that's a major thing for us, forsy. It will probably take a bit of time until all the countries in Europe get, the approvals, the reimbursement approval, because there is always some logistics and some, regulatory paths that you have to follow. But, in Europe it's a major thing. It reduces the burden for the patients as it's a huge competitive edge because the competitors don't have this, the 1 to 4 weeks regimen.

And in terms of timing of approval to the US, I think it's a bit early to reply on that. What we can show is that the fact that it was approved in Europe is going, we think it's going to accelerate the approval, potentially the approval in the US, but it's too early to say.

Okay, and then with respect to PRX 115 in gout, can you maybe provide us with some additional insight into how this agent might be positioned. In the gout market, if it were to be approved, and what do you expect the principal competitive advantages to look like and how that might translate commercially, given the fact that gout is so much larger of an indication than anything that the company has previously gotten product approvals for, clearly gout is very different from Gauthier or Fabri. And in particular, it would be helpful to understand whether you expect to have not only advantages in dosing frequency, meaning improved convenience, but also potential safety.

Thank you.

So Ram, I would like to answer you if it's okay. First, just to add on, to tap on what Gilad mentioned. He does, and I say it again and again, and I think the picture is very much pink. They do very nicely. And I think and positive that the once in 4 weeks approval will enhance significantly their positioning wherever it is approved on the label of course with regard to the US, Ky will take their decisions and we will update when we can. Again, we are very pleased and, you can see our trajectory or guidance for 2026. And as I said, in the past, we expect good years ahead of us.

Second, with regard to 115, as we enter, as we speak, we are screening and enrolling patients to this study. The design of the study is out there. We have, 5 arms. One is placebo. One arm is 1 month without methotrexate. And then there are three arms, one's in 41 in 6, and one in 8 weeks with methotrexate. Clearly, hitting, 1 month without methotrexate or once in 6 or 8 weeks with methotrexate is a significant differentiation, if I may say.

In addition to that, and we cannot say right now, of course, because the phase two is the multiple dose study, we will know by the end of the study and what we think that the current molecule, I mean the enzyme with the peg, and we did a couple of changes to that and we have a small peg. This is not the time to go to all the differences, but it's public, of course.

Potentially we have a better, we expect a favorable immunogenicity or immunogenic profile. This we'll see by the end of phase two. With all that, I think if indeed we hit, we have a very nice potential asset. I hope I -- in addition, I just want to add I think that by the time we will get to the market, which will be 2031, 2032, depends on the phase three enrollment time, etc.

This specific, I would say uncontrolled gout segment will be bigger. I would dare to get to $2 billion market, maybe more, and I think if indeed we come up with differentiated asset, it will grab or we'll be able to achieve a nice market share.

Okay, that's very helpful. One last question for me, PRX 119, I was wondering if you could elaborate on specifically which rare renal conditions you expect to target with this asset and what kinds of markets these represent and if any of them are. Pediatric in nature and might potentially be allow you to be eligible if you know there's one day an approval for a priority review voucher. Just wanted to better understand, which renal markets you are looking at and what kinds of commercial opportunities these might provide.

So we will update, as we said, I hope by the end of Q2. By then we'll have all the, we expect to have all the data from additional experiments that we are conducting, the specific indication, the specific mechanism of action, which is very much important. We target the high unmet need renal indication, and we think that if this potential mechanism of action will work, it will be very interesting for the patients. So, please bear with us a few more months and we'll update accordingly.

If it's okay.

John Vandermosten, Zacks.

Great, thank you for taking my questions. So, with the Frio and the 4 week dosing, what is the, estimated timeline for rollout, and when will it be available to patients?

You speak about it probably once in 4 weeks in the EU? Correct. Okay, so in some of the markets it is, will be available very soon. And maybe Gilad has the exact details. I don't have it in front of my eyes. In other markets it will take a few months.

I'm speaking about the EU. Outside the EU, it's a process which I don't have right now. We think relatively in a short time. So we will see, I told, for the second half of 2026 already a trend, I hope, or I cannot tell you it will happen today because it was just approved on the 5th of March, okay, but in some of the markets it is actually approved the day after. In some of the markets there is a procedure, and, of course there should be a reimbursement scheme around, although the price as far as we know, is unchanged, so it's not supposed to be a hurdle. Maybe Gillard can tap on that.

Yes, so we just said to John that the approval was just received, so the K themselves didn't analyze the country by country because it is a country by country in Europe. I would assume that, I mean, based on what we know now and we are waiting for further information from them, we expect the effect to start taking place as of the second half of 2026 and obviously much more in 2027 and further.

Okay, and is there a physician education effort that will accompany that kind of roll out, I guess? I mean, I know it's different in Europe than in the United States, but will that that be required?

I think is on it, of course, in a professional way, so they are in touch with all treating physicians and all the relevant stakeholders across Europe and further market that this new or additional regimen will be approved, so I'm positive it is.

Okay, great, thanks for taking my questions.

Thank you.

We have reached the end of our Question-and-answer session, I would like to turn the conference back over to draw for closing remarks.

So thank you and thank you everybody for joining us.

We are looking, I would say, into 2026 with a smile, and I am happy to update you within about I would say two months on the outcomes of the first quarter of this year.

Thank you very much.

Thank you, this will conclude today's conference. You may disconnect your lines at this time and thank you for your participation.

Thank you.